FDA Adverse Event
Summary report: N
SYNOVIS DURA-GUARD DURAL REPAIR PATCH
MDR report key: 2954018
·
Received January 29, 2013
Report
- Report Number
- 2954018
- Date Received
- January 29, 2013
- Date of Event
- July 8, 2012
- Report Date
- January 29, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- GXQ
- Report Source
- User Facility report
- Reporter Location
- MN, US
Narratives
Description of Event or Problem · 1
PATIENT HAD IMPLANT OF SYNOVIS DURA-GUARD DURAL REPAIR PATCH DURING CRANIOTOMY SURGERY. DEVELOPED INFECTION WITH PSEUDOMONAS AERUGINOSA APPROXIMATELY SEVEN WEEKS LATER.INFECTION CONTROL DEPT IS REPORTING DUE TO REQUEST FROM DEPT OF HEALTH AND CDC TO REPORT ANY INFECTIONS WITH USE OF THE DURA-GUARD DURAL REPAIR PATCH.MANUFACTURER RESPONSE FOR DURAGUARD, SYNOVIS DURA-GUARD DURAL REPAIR PATCH (PER SITE REPORTER).NONE AT THIS TIME. WORKING WITH THE CDC AND OUR DEPT OF HEALTH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CRANIOTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38242 | SYNOVIS DURA-GUARD DURAL REPAIR PATCH | DURA SUBSTITUTE | GXQ | BAXTER HEALTHCARE CORPORATION | * | 5793442-1729122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |